Technical Lead Engineer (3 Year FTC)

Viatris; Inverin; On-site; EUR 1 - 2; Full time

Job summary

Mylan Teoranta Viatris is seeking a Technical Lead Engineer for our sterile injectable fill-finish facility in Ireland. You will provide technical leadership, engineering support, and maintenance reliability oversight, with emphasis on HVAC, clean utilities, and GMP-compliant systems.

Lead for the new cartridge filling line and support syringe/vial operations, ensuring compliant, safe manufacturing processes.

Qualifications

• The role requires technical leadership in sterile injectable fill-finish manufacturing.
• Experience with HVAC, clean utilities, and GMP-compliant facility systems.

Responsibilities

• Lead engineering activities to maintain inspection readiness and regulatory compliance.
• Provide technical leadership for HVAC, cleanroom infrastructure, utilities, and process equipment.
• Develop and maintain qualification lifecycle documents and maintenance programs.
• Drive reliability, preventive maintenance, and continuous improvement across production assets.

Job description

Mylan Teoranta

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Technical Lead Engineer is responsible for providing technical leadership, engineering support, and maintenance reliability oversight within a sterile injectable fill finish manufacturing facility. The role has primary responsibility for ensuring plant inspection readiness across engineering systems, with particular emphasis on HVAC, clean utilities, facility infrastructure, preventive maintenance programs, and associated Standard Operating Procedures (SOPs).

The successful candidate will act as the engineering lead for the new product program proposed for the cartridge filling line while providing technical support for existing syringe and vial filling operations. The role is responsible for developing and maintaining qualification lifecycle documents, driving maintenance excellence initiatives, improving equipment reliability, and supporting process development activities to ensure compliant, safe, and efficient manufacturing operations.

The Technical Lead will work closely with Operations, Quality Assurance, Validation, Maintenance, Facilities, and external contractors to ensure all systems remain in a sustained state of control and regulatory compliance.

This role is a critical engineering leadership position responsible for ensuring the reliable, compliant, and efficient operation of sterile fill finish manufacturing systems while driving engineering excellence, maintenance reliability, and continuous inspection readiness.

Key Responsibilities

• 1) Plant Inspection Readiness & Compliance Leadership
  • - Lead engineering activities to maintain continuous regulatory inspection readiness.
  • - Ensure HVAC systems, cleanroom infrastructure, utilities, and process equipment comply with GMP requirements and site procedures.
  • - Drive remediation activities arising from audits, inspections, deviations, CAPAs and technical investigations.
  • - Support regulatory inspections and customer audits as the technical subject matter expert for facilities and engineering systems.
  • - Ensure engineering documentation is maintained in an audit-ready state at all times.
  • - Periodically review engineering systems for compliance, risk, and operational effectiveness.
• 2) HVAC & Utilities Systems
  • - Provide technical leadership and oversight of critical facility systems including:
  • • o HVAC and cleanroom environmental control systems
    • o Clean Steam systems
    • o Water for Injection (WFI)
    • o Purified Water systems
    • o Compressed gases
    • o Process chilled water
    • o Building Management Systems (BMS)
    • o Environmental monitoring support systems
  • - Ensure robust preventative maintenance and reliability strategies are implemented for all GMP utilities.
  • - Drive continuous improvement of utility performance through trend analysis and reliability programs.
  • - Support qualification, requalification and periodic review activities for critical utility systems.
• 3) Maintenance Excellence & Reliability Engineering
  • - Champion maintenance reliability best practices across all production and utility assets.
  • - Develop and optimize preventative maintenance (PM) programs using risk-based and reliability centered maintenance principles.
  • - Lead root cause investigations and implementation of sustainable corrective actions for equipment failures.
  • - Establish & report KPI's
  • - Drive predictive maintenance initiatives where appropriate.
  • - Partner with maintenance teams to improve asset lifecycle management and spare parts strategies.
  • - Promote a culture of reliability, ownership, and continuous improvement.
• 4) Cartridge Filling Line Technical Leadership
  • - Serve as Engineering Lead for the cartridg